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FDA Approves Melanoma Drug Yervoy

FDA approves first ever drug shown to help late-stage melanoma patients live longer…

Last month the FDA announced its approval of a new treatment for late stage metastatic melanoma. The drug – known as Yervoy (ipilimumab) and manufactured by Bristol-Myers – is the first ever treatment shown to increase the life expectancy of late-stage melanoma patients.

In clinical trials involving 676 late-stage melanoma patients, for all of whom other treatments had failed and surgery was not an option, those patients taking Yervoy survived on average, for 10 months after commencing the trial compared to those taking other experimental treatments who survived an average of just 6.5 months.

Bristol Myers also announced that its drug also helps extend survival when used as a first-line treatment for inoperable stage III or stage IV melanoma. Details have yet to be published however the company will report the findings at the June meeting of the American Society of Clinical Oncology.

While the study results and the consequent approval of Yervoy are a promising step forward for the treatment of the deadly skin cancer, experts note that the drug is not a cure, and like similar drugs, Yervoy can also have serious side effects.

Yervoy is man-made antibody, otherwise known as a monoclonal antibody, which effectively locks a switch on immune cells called CTLA-4. Cancers use these switches to turn of the body’s immune responses; therefore securing these triggers slows the progression of the disease.

Unfortunately, blocking these switches commonly caused side effect such as skin rashes, fatigue, diarrhea, hormone deficiencies, and colitis (inflammation of the intestines). In more severe cases the drug can even induce fatal autoimmune reactions. During the trail, 13 percent of participants experience severe or fatal side effects.

For this reason the FDA has requested Bristol Myers to perform a risk evaluation and mitigation strategy (REMS) to help doctors avoid complications and counteract adverse reactions.